Analyzing data regarding reported health problems from dietary supplements, the U.S. Government Accountability Office (GAO) found that from 2008 through 2011, FDA received 6,307 reports of health problems—adverse event reports (AER)—for dietary supplements. Seventy one percent of these reports came from industry as serious AERs as required by law, and most of these were linked to supplements containing a combination of ingredients, such as vitamins and minerals or were otherwise not classified within FDA’s product categories, the report noted.

However, according to the GAO report, FDA may not be receiving information on all adverse events, as consumers and others may not be voluntarily reporting these events to FDA, although they may be contacting poison centers about some of these events. From 2008 to 2010, these centers received more than 1,000 more reports of adverse events linked to dietary supplements than did FDA for the same period. FDA officials said they are interested in determining whether the poison center data could be useful for their analysis and have held discussions with American Association of Poison Control Centers representatives, but cost is a factor.

GAO recommended that FDA explore options to obtain poison center data, if determined to be useful; collect information on how it uses AERs; provide more information to the public about AERs; and establish a time frame to finalize guidance related to GAO’s 2009 recommendations. FDA generally concurred with each of GAO’s recommendations.

Responding to the report, Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), Washington, D.C., said his organization believes the recommendations in the GAO report are “reasonable and open the door for further dialogue with FDA as to how industry and government can continue to work together to help ensure consumers are making wise decisions about incorporating dietary supplements into their health regimens.”

CRN supports transparency with respect to AER reporting, Mr. Mister noted, “to the extent that consumers will benefit from that transparency and that industry will not be made the victim of frivolous lawsuits because of it. However, along with transparency, there must be context and education, so that consumers are not misled and clearly understand that just because a consumer may have taken a product at the same time they experience an adverse symptom, it may not translate into a causal relationship between a product and the adverse event itself.

“Finally, we commend the GAO for urging FDA to finalize its draft guidance on 1) New Dietary Ingredients and 2) distinguishing liquid dietary supplements from conventional foods,” he continued. “In their final form, these guidance documents will provide much needed clarity to companies manufacturing and marketing dietary supplements.”

Dr. Cara Welch, senior vice president of scientific and regulatory affairs, Natural Products Association (NPA), Washington, D.C., said the GAO report confirmed the importance of the AER law. “The GAO report helps demonstrate that consumer safety is the number one priority for supplement manufacturers. NPA echoes the GAO recommendation that FDA expand their information collection by partnering with poison control centers and educating the public.”

Further, she commented, “While the FDA increased the number of inspections from 120 in 2008 to more than 400 in 2012, NPA is encouraged that they only had to take 19 actions related to AER violations during this time. Still, we are concerned any time a violation may be found. NPA offers extensive educational opportunities to help supplement makers comply with government regulations and recently partnered with other industry members to offer widespread education on adverse event reporting.”

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